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Sponsored by: |
National Institute of Neurological Disorders and Stroke (NINDS) |
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Information provided by: | National Institutes of Health Clinical Center (CC) |
ClinicalTrials.gov Identifier: | NCT00001778 |
Objective:
Human T-lymphotropic virus type-I-associated myelopathy / tropical spastic paraparesis (HAM/TSP) is a rare neurologic disorder that affects less than 5% of patients infected with the HTLV-I virus. The purpose of this protocol is to study the natural history of HAM/TSP with emphasis on defining its virological and immunological changes with respect to clinical progression.
Study Population:
Patients with HAM/TSP who fulfill World Health Organization diagnostic criteria are eligible to participate in this protocol. Asymptomatic seropositive individuals and individuals with indeterminate HTLV-1 serology are also eligible to participate.
Design and Outcome Measures:
A longitudinal assessment of clinical, virological and immunological progression in HAM/TSP will be accomplished through periodic testing and evaluation. Asymptomatic seropositive individuals, those with serodeterminate HTLV-I serology and normal volunteers may serve as controls. Longitudinal standardized neurological examinations will be performed. Longitudinal samples of serum, plasma, and lymphocytes will be obtained from participants. Lumbar punctures may be performed on individuals with HAM/TSP. These samples will be used virological and immunological assays. A focus is on the relationships between the characteristics of viral infection, the immune response and the genetic makeup.
Condition |
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HTLV-I Infection Tropical Spastic Paraparesis |
Study Type: | Observational |
Official Title: | Immuno-Virological Evaluation of Human T Cell Leukemia Virus Type-1 Associated Myelopathy (HAM/TSP) |
Estimated Enrollment: | 150 |
Study Start Date: | December 1997 |
Objective:
Human T-lymphotropic virus type-I-associated myelopathy / tropical spastic paraparesis (HAM/TSP) is a rare neurologic disorder that affects less than 5% of patients infected with the HTLV-I virus. The purpose of this protocol is to study the natural history of HAM/TSP with emphasis on defining its virological and immunological changes with respect to clinical progression.
Study Population:
Patients with HAM/TSP who fulfill World Health Organization diagnostic criteria are eligible to participate in this protocol. Asymptomatic seropositive individuals and individuals with indeterminate HTLV-1 serology are also eligible to participate.
Design and Outcome Measures:
A longitudinal assessment of clinical, virological and immunological progression in HAM/TSP will be accomplished through periodic testing and evaluation. Asymptomatic seropositive individuals, those with serodeterminate HTLV-I serology and normal volunteers may serve as controls. Longitudinal standardized neurological examinations will be performed. Longitudinal samples of serum, plasma, and lymphocytes will be obtained from participants. Lumbar punctures may be performed on individuals with HAM/TSP. These samples will be used virological and immunological assays. A focus is on the relationships between the characteristics of viral infection, the immune response and the genetic makeup.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | Yes |
EXCLUSION CRITERIA:
Contact: Patient Recruitment and Public Liaison Office | (800) 411-1222 | prpl@mail.cc.nih.gov |
Contact: TTY | 1-866-411-1010 |
United States, Maryland | |
NCI Frederick Cancer Research Center | Recruiting |
Frederick, Maryland, United States, 21702-1201 | |
National Institutes of Health Clinical Center, 9000 Rockville Pike | Recruiting |
Bethesda, Maryland, United States, 20892 | |
United States, Pennsylvania | |
Hershey Medical Center | Recruiting |
Hershey, Pennsylvania, United States, 17033 | |
United States, Virginia | |
Eastern Virginia Medical College | Recruiting |
Norfolk, Virginia, United States |
Study ID Numbers: | 980047, 98-N-0047 |
Study First Received: | November 3, 1999 |
Last Updated: | July 18, 2008 |
ClinicalTrials.gov Identifier: | NCT00001778 |
Health Authority: | United States: Federal Government |
Immune Response Sero-Indeterminant Transmission Tropical Spastic Paraparesis |
Viral Load HTLV-I HAM/TSP |
Spastic paraparesis Paresis Spinal Cord Diseases Leukemia-Lymphoma, Adult T-Cell Paraparesis, Tropical Spastic Central Nervous System Diseases Paraparesis, Spastic Immunologic Deficiency Syndromes Virus Diseases Signs and Symptoms |
Leukemia Central Nervous System Infections Leukemia, T-Cell Neurologic Manifestations Myelitis HTLV-I Infections Paraparesis Retroviridae Infections Tropical Spastic Paraparesis |
RNA Virus Infections Immune System Diseases Nervous System Diseases |
Central Nervous System Viral Diseases Deltaretrovirus Infections Infection |